Global Quality Manager

Jobtailor; Warszawa; On-site; PLN 90,000 - 150,000; Full time

Job summary

Jobtailor is seeking a Quality Compliance Specialist to establish KPI reporting across a global affiliate network and coordinate inspection readiness. You will ensure QMS compliance with current policies, SOPs, and documentation, while integrating affiliate SOPs with global procedures and supporting US operations.

The role requires 2+ years in a pharmaceutical GxP environment, strong communication skills, and experience with SAP/Veeva/TrackWise.

Qualifications

• Bachelor’s degree in life sciences or related field and 2+ years in a GxP-regulated pharma role.
• Strong knowledge of quality systems, compliance processes, and ICH guidelines.
• Ability to work independently and across global teams with minimal supervision.

Responsibilities

• Establish and maintain processes for reporting Quality KPIs across global affiliates.
• Coordinate inspection readiness activities throughout the global affiliate network.
• Support quality management system compliance activities; keep docs current and aligned with requirements.
• Manage integration of Affiliate Quality SOPs with Global CSL procedures and updates.
• Provide quality support to US Commercial Operations as required.
• Support Product Technical Complaint activities for the US market.
• Support Global Change Control, Deviation, and CAPA processes across regions.
• Support and perform product release activities for the US market and exports; collaborate with site reps.
• Lead or support implementation of global electronic quality systems (SAP, Master Data Governance, DocNet).
• Ensure clear communication with stakeholders on progress, risks, and compliance.

Skills

Quality Management Systems

GxP Compliance

CAPA Development

Electronic Quality Systems

Pharmaceutical Industry Regulations

Education

Bachelor's degree in Life Sciences, a Scientific Discipline, Project Management, Business Management, or related field

Tools

SAP

Veeva

TrackWise

SharePoint

Microsoft Office

Job description

• Establish and maintain processes for reporting Quality KPIs across global affiliates.


• Coordinate inspection readiness activities throughout the global affiliate network.


• Support quality management system compliance activities, ensuring policies, SOPs, work instructions, and related documentation remain current, effective, and aligned with business and regulatory requirements.


• Manage the integration of Affiliate Quality SOPs with Global CSL procedures and facilitate procedure updates to incorporate affiliate and local requirements.


• Provide quality support to US Commercial Operations as required.


• Support Product Technical Complaint (PTC) activities for the US market.


• Support Global Change Control, Deviation, and CAPA processes across assigned regions.


• Support and perform product release activities for the US market and Kankakee-manufactured export products, collaborating with manufacturing site representatives as needed.


• Lead and/or support implementation of global electronic quality systems such as SAP, Master Data Governance, and DocNet.


• Ensure effective communication with internal and external stakeholders regarding progress, improvements, risks, and compliance-related matters.

Requirements

• Bachelor's degree in Life Sciences, a Scientific Discipline, Project Management, Business Management, or a related field.


• Minimum of 2 years' experience in a pharmaceutical industry GxP-regulated role.


• Strong knowledge of quality systems, compliance processes, and pharmaceutical industry regulations, including ICH guidelines and industry standards.


• Demonstrated ability to work independently, take ownership of assigned projects, and deliver results with minimal supervision.


• Excellent interpersonal skills with the ability to build effective cross-functional relationships and work successfully within global teams.


• Strong organizational, communication, influencing, and stakeholder management skills.


• Ability to identify process improvement opportunities and implement practical, innovative solutions.


• Working knowledge of CAPA development and quality system methodologies is preferred.


• Experience supporting or implementing electronic quality systems and digital quality tools is advantageous.


• Strong computer skills, including Microsoft Office applications.


• Experience with SAP, Veeva, TrackWise, SharePoint, collaboration tools, or quality databases is desirable.


• Excellent written and verbal communication skills in English.

Core Competencies

Demonstrates expertise in quality management systems, compliance processes, and regulatory requirements within the pharmaceutical industry, with a strong focus on effective communication and cross-functional collaboration.

Highest-signal resume keywords

• Quality Management Systems


• GxP Compliance


• CAPA Development


• Electronic Quality Systems


• Pharmaceutical Industry Regulations

ATS Optimization Keywords

Hard Skills

• Quality Systems


• Process Improvement


• Project Management


• Regulatory Compliance


• Inspection Readiness

Soft Skills

• Interpersonal Skills


• Organizational Skills


• Communication Skills


• Stakeholder Management


• Influencing Skills

Industry Keywords

• ICH Guidelines


• Pharmaceutical Industry


• GxP-Regulated Role


• Quality KPIs


• Product Technical Complaint

Tools & Technologies

• SAP


• Veeva


• TrackWise


• SharePoint


• Microsoft Office